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Frequently Asked Questions

 

 

 

Patients, Parents, or Legal Guardians

Q:  Who is eligible for obtaining cannabis oil?

A:  Currently, the law restricts the use of cannabis oil to a Board of Pharmacy-registered patient or, if such patient is a minor or an incapacitated adult as defined in 18.2-369, such patient's parent or guardian for treatment or to alleviate the symptoms of any diagnosed condition or disease determined by the practitioner to benefit from such use.

Q:  Does the law provide for an affirmative defense for possession of cannabis oil?

A:  As of July 1, 2020 an affirmative defense is no longer required as a patient, parent, legal guardian or registered agent may legally possess cannabis oil under the following provision: 
§ 18.2-250.1 C of the Code of Virginia states: the provisions of this section involving marijuana in the form of cannabis oil as those terms are defined in § 54.1-3408.3, shall not apply to any person who possesses such oil pursuant to a valid written certification issued by a practitioner in the course of his professional practice pursuant to § 54.1-3408.3 for treatment or to alleviate the symptoms of (i) the person's diagnosed condition or disease, (ii) if such person is the parent or legal guardian of a minor or of an incapacitated adult as defined in § 18.2-369, such minor's or incapacitated adult's diagnosed condition or disease, or (iii) if such individual has been designated as a registered agent pursuant to § 54.1-3408.3, the diagnosed condition or disease of his principal or, if the principal is the parent or legal guardian of a minor or of an incapacitated adult as defined in § 18.2-369, such minor's or incapacitated adult's diagnosed condition or disease, or (iii) if such person has been designated as a registered agent pursuant to § 54.1-3408.3, the diagnosed condition or disease of his principal or, if the principal is the parent or legal guardian of a minor or of an incapacitated adult as defined in § 18.2-369, such minor’s or incapacitated adult’s diagnosed condition or disease.

Q: Do I need a new written certification now that a patient, parent, legal guardian or registered agent may legally possess cannabis oil?

A: No, as long as your current written certification has not expired it will be accepted at the pharmaceutical processor.  The next time you renew your written certification, the practitioner will provide you with an updated version.

Q: What other conditions must be met to legally possess cannabis oil?

A:  In addition to being issued a valid written certification from a Board of Pharmacy-registered practitioner, the patient and, if such patient is a minor or an incapacitated adult as defined in 18.2-369, such patient's parent or guardian, must obtain registration from the Board of Pharmacy.  The written certification alone does not satisfy the conditions for legally possessing cannabis oil.

Q: When may a patient, parent, legal guardian apply for board registration? 

A: Each parent or legal guardian who intends to possess cannabis oil must be issued a written certification in his or her name.  Additionally, each parent or legal guardian issued a written certification must obtain board registration in order to possess the oils.

Q:  What is the registration fee for a patient?

A:  The initial registration fee is $50 and the annual renewal fee is $50.

Q:  What is the registration fee for a parent or legal guardian?

A:  The initial registration fee is $25 and the annual renewal fee is $25.

Q:  If the patient is a minor or an incapacitated adult as defined in 18.2-369, who must obtain board registration?

A:  The parent or legal guardian must apply for board registration for both the patient and for himself or herself as the parent or legal guardian. 

Q:  Must each parent or legal guardian be issued a written certification by the practitioner?

A:  Each parent or legal guardian who intends to possess cannabis oil must be issued a written certification in his or her name.  Additionally, each parent or legal guardian issued a written certification must obtain board registration in order to possess the oils.

Q:  Is cannabis oil currently available to obtain from a pharmaceutical processor located in Virginia?

A:  No.  The Board awarded conditional approval to 5 pharmaceutical processors in December 2018.  Three of those pharmaceutical processors are now operational and in the process of cultivating Cannabis.  It will take approximately 4-6 months to cultivate, produce, and test the products prior to dispensing. It is anticipated that cannabis oil products will be available in late Summer 2020.

Q: Once I am registered in Virginia as a patient for cannabis oil can I purchase Cannabis products in other states?

A: No, your registration as a patient for cannabis oil is only valid in Virginia as Virginia does not have reciprocity with other states

Registered Agent

Q: Who should register as a registered agent?

A: A patient, or the patient’s parent or legal guardian, may choose a registered agent to receive cannabis oil on behalf of the patient. 

Q: How many patients can I act as the registered agent for?

A: An individual may serve as a registered agent for no more than 2 registered patients.

Q:  Does the law provide for an affirmative defense for possession of cannabis oil?

A:  As of July 1, 2020 an affirmative defense is no longer required as a patient, parent, legal guardian or registered agent may legally possess cannabis oil under the following provision: 
§ 18.2-250.1 C of the Code of Virginia states: the provisions of this section involving marijuana in the form of cannabis oil as those terms are defined in § 54.1-3408.3, shall not apply to any person who possesses such oil pursuant to a valid written certification issued by a practitioner in the course of his professional practice pursuant to § 54.1-3408.3 for treatment or to alleviate the symptoms of (i) the person's diagnosed condition or disease, (ii) if such person is the parent or legal guardian of a minor or of an incapacitated adult as defined in § 18.2-369, such minor's or incapacitated adult's diagnosed condition or disease, or (iii) if such individual has been designated as a registered agent pursuant to § 54.1-3408.3, the diagnosed condition or disease of his principal or, if the principal is the parent or legal guardian of a minor or of an incapacitated adult as defined in § 18.2-369, such minor's or incapacitated adult's diagnosed condition or disease, or (iii) if such person has been designated as a registered agent pursuant to § 54.1-3408.3, the diagnosed condition or disease of his principal or, if the principal is the parent or legal guardian of a minor or of an incapacitated adult as defined in § 18.2-369, such minor’s or incapacitated adult’s diagnosed condition or disease.

Q:  What other conditions must be met to legally possess cannabis oil?

A: A registered agent may apply for registration with the Board of Pharmacy when a patient requests that they obtain cannabis oil on the patient’s behalf.

Q:  What is the registration fee for a registered agent?

A:  The initial registration fee is $25 and the annual renewal fee is $25.

 

Practitioners

Q:  Who is eligible for obtaining cannabis oil?

A:  Currently, the law restricts the use of cannabis oil to a Board of Pharmacy-registered patient or, if such patient is a minor or an incapacitated adult as defined in 18.2-369, such patient's parent or guardian for treatment or to alleviate the symptoms of any diagnosed condition or disease determined by the practitioner to benefit from such use.

Q: What practitioners are eligible to obtain board registration for issuing a written certification for recommending the use of cannabis oil?

A: A practitioner of medicine or osteopathy, or a physician assistant, licensed by the Board of Medicine, or a nurse practitioner jointly licensed by the Board of Medicine and the Board of Nursing.

Q:  Does the law provide for an affirmative defense for possession of cannabis oil?

A:  As of July 1, 2020 an affirmative defense is no longer required as a patient, parent, legal guardian or registered agent may legally possess cannabis oil under the following provision: 
§ 18.2-250.1 C of the Code of Virginia states: the provisions of this section involving marijuana in the form of cannabis oil as those terms are defined in § 54.1-3408.3, shall not apply to any person who possesses such oil pursuant to a valid written certification issued by a practitioner in the course of his professional practice pursuant to § 54.1-3408.3 for treatment or to alleviate the symptoms of (i) the person's diagnosed condition or disease, (ii) if such person is the parent or legal guardian of a minor or of an incapacitated adult as defined in § 18.2-369, such minor's or incapacitated adult's diagnosed condition or disease, or (iii) if such individual has been designated as a registered agent pursuant to § 54.1-3408.3, the diagnosed condition or disease of his principal or, if the principal is the parent or legal guardian of a minor or of an incapacitated adult as defined in § 18.2-369, such minor's or incapacitated adult's diagnosed condition or disease, or (iii) if such person has been designated as a registered agent pursuant to § 54.1-3408.3, the diagnosed condition or disease of his principal or, if the principal is the parent or legal guardian of a minor or of an incapacitated adult as defined in § 18.2-369, such minor’s or incapacitated adult’s diagnosed condition or disease.

Q: Do I need a new written certification now that a patient, parent, legal guardian or registered agent may legally possess cannabis oil?

A: No, as long as your current written certification has not expired it will be accepted at the pharmaceutical processor.  The next time you renew your written certification, the practitioner will provide you with an updated version.

Q:  What other conditions must be met to legally possess cannabis oil?

A:  In addition to being issued a valid written certification from a Board of Pharmacy-registered practitioner, the patient and, if such patient is a minor or an incapacitated adult as defined in 18.2-369, such patient's parent or guardian, must obtain registration from the Board of Pharmacy. A registered agent, if one is chosen by a patient, must also obtain registration from the Board of Pharmacy. The written certification alone does not satisfy the conditions for legally  possessing cannabis oil.

Q: Must a practitioner obtain Board of Pharmacy registration prior to or continuing to issue a written certification for a patient to possess cannabis oil?  

A: Yes, before a practitioner can issue or continue issuing written certifications, he or she must register with the Board of Pharmacy. Learn More about practitioner registration.

Q:  What is the registration fee for a practitioner?

A:  The initial registration fee is $50 and the annual renewal fee is $50.

Q:  May a practitioner issue a prescription for the oil? 

A:  No.  A written certificate must be issued.

Q:  Where may a practitioner locate the written certification form?

A:The Board of Pharmacy will email the practitioner a link to the written certification form once the board issues the practitioner registration. Please allow 7-10 days for processing the registration application and receiving the email with the link to the written certification.

 

 

Pharmaceutical Processor Permit

Q:  What is the process for applying for a pharmaceutical processor permit?

A:  The application process for pharmaceutical processor permits will occur in three stages: submission of initial application, awarding of conditional approval, and granting of a pharmaceutical processor permit.   In June 2020, the board rescinded the conditional approval and denied the pharmaceutical processor permit originally issued in Health Service Area I.  The Board anticipates opening a Request for Application in Health Service Area I later this year.  A Notice will be posted on Regulatory Town Hall once it has opened.   

Q:  How do I become a registered user of Regulatory Town Hall?

A:  Click here to become a registered user of Regulatory Town Hall and receive email notifications regarding the notice for the Request for Application for pharmaceutical processors, regulatory actions, and meetings of the Board of Pharmacy within the Health and Human Resource Secretariat.

Q: How many pharmaceutical processor permits will be issued?

A: §54.1-3442.6 of the Code of Virginia restricts the number of permits that the Board may issue or renew in any year to a maximum of 5 permits, one for each health service area established by the Board of Health.

Q: How many cannabis dispensing facilities will there be and when will the cannabis dispensing facilities be open?

A: The Board may issue or renew a maximum of 5 permits for cannabis dispensing facilities in each health service area.  The cannabis dispensing facility must be owned in part by the pharmaceutical processor permitted in that area.  Emergency regulations related to these facilities will tentatively become effective in January 2021.  Applications for permitting cannabis dispensing facilities may be accepted in 2021 after the emergency regulations become effective.

Q:  Where may I find a listing of the five health service areas as established by the Board of Health?

A: Click here for a list of the five health service areas.

Q:  What are the three stages in the application process for a pharmaceutical processor permit?

A:  Submission of initial application, awarding of conditional approval, and granting of a pharmaceutical processor permit.  Refer to Regulations 18VAC110-60-110 through 18VAC110-60-130.

Q:  What are the licensure fees associated with obtaining a pharmaceutical processor permit?

A:  The initial application fee is $10,000.  The permit fee is $60,000 and the annual renewal fee is $10,000.

Pesticides and the Assigning of Expiration Dates for Cannabis Oil Products

Q: Under what conditions may a pharmaceutical processor use pesticides during the cultivation, extraction, production, or manufacturing process of cannabis oil?

A: Per Regulation 18VAC110-60-280, a pharmaceutical processor may only use pesticides for the purposes of addressing an infestation that could result in a catastrophic loss of Cannabis crops.
When a pesticide is used, the pharmaceutical processor should immediately notify the board office and maintain a record on its premises of the following information:

a. The name, signature and applicator certification number, issued by the Virginia Department of Agriculture and Consumer Services; if applicable, of the individual who applied the pesticide;
b. The date and time of the application;
c. The U.S. Environmental Protection Agency (EPA) registration number or, if exempt from EPA’s registration process under Section 25(b) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), the Chemical Abstract Service (CAS) number of the pesticide applied;
d. Active ingredients of the pesticide applied;
e. Brand name and product name of the pesticide applied;
f. The restricted entry interval from the product label of any pesticide applied;
g. The radio-frequency identification (RFID) tag number of the cannabis plant(s) that the pesticide was applied to or if applied to all plants throughout the pharmaceutical processor, a statement to that effect and principle pests to be controlled; and
h. The amount of pesticide concentrate and amount of diluent, by weight or volume, in mixture applied.
The pharmaceutical processor should have the original label for all pesticide used to address an infestation that could result in catastrophic loss.

Q: What pesticides does the board authorize a pharmaceutical processor to use to address an infestation that could result in a catastrophic loss of Cannabis crops?

A: The Board authorizes pharmaceutical processors to use a pesticide, to address an infestation that could result in a catastrophic loss of Cannabis crops, which satisfies the following criteria:

The pharmaceutical processor is responsible for determining which pesticides can be used on its crops in accordance with the above criteria and assumes all risk associated with the use, including possible crop loss. This information is not an endorsement of any product and shall not be considered a guaranty of efficacy or without risk of harm to the crop on which it is applied.

Q: What criteria will the Board use to determine compliance with the pesticide chemical residue testing requirements for pharmaceutical processors?

A: Per 18VAC110-60-300, for purposes of the pesticide chemical residue test, a sample of cannabis oil product shall be deemed to have passed if it satisfies the most stringent acceptable standard for a pesticide residue in any food item as set forth in Subpart C of the federal Environmental Protection Agency's regulations for Tolerances and Exemptions for Pesticide Chemical Residues in Food, 40 CFR Part 180.

Compliance with 18VAC110-60-300 may be satisfied by testing all pesticide analytes listed in the Farrer DG. Technical report: Oregon Health Authority’s process to decide which types of contaminants to test for in cannabis. Oregon Health Authority. 2015 December or the most current report authorized by the Oregon Health Authority identifying pesticides for testing, and adhering to the corresponding action levels identified in the report.

Q: What criteria will the Board use to determine compliance with assigning an expiration date for cannabis oil products?

A: Per Regulation 18VAC110-60-300, a pharmaceutical processor shall assign an expiration date to the product that is based upon validated stability testing that addresses product stability when opened and the shelf-life for unopened products.

A pharmaceutical processor may assign an expiration date not to exceed 6-months from the date of production. The expiration date may be extended if validated stability testing supports such extension.